Cord blood platelet-poor plasma eye drops for dry eye

Cord Blood Platelet Poor Plasma Eye Drops

This trial tests whether cord blood platelet-poor plasma eye drops plus 0.1% cyclosporine help adults with severe dry eye disease.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Academic / other)
• Locations: 1 site (Milan)
• Trial ID: NCT07089511 on ClinicalTrials.gov

What this trial studies

This interventional trial enrolls adults with severe dry eye disease defined by modified Oxford corneal fluorescein staining and either low Schirmer or high OSDI/symptom scores. Participants receive either cord blood platelet-poor plasma eye drops combined with 0.1% cyclosporine or 0.15% hyaluronic acid with 0.1% cyclosporine, with outcomes monitored at scheduled clinic visits. Key measurements include corneal staining, symptom scores (OSDI and symptom severity), and tear production (Schirmer) to document epithelial and symptomatic changes. The approach leverages regenerative and immunomodulatory factors present in cord blood plasma that have shown epithelial benefits in prior observational work.

Who should consider this trial

Good fit: Adults aged 18 or older with severe dry eye defined by a modified Oxford corneal staining score of 3–5 plus either Schirmer <10 mm/5 min or OSDI ≥30 who can provide informed consent and follow study procedures are ideal candidates.

Not a fit: Patients with mild dry eye, other primary ocular surface diseases, active ocular infection, known allergies to study components, or who do not meet the specified severity criteria are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this treatment could improve corneal healing and reduce symptoms in patients with severe dry eye who do not respond adequately to standard artificial tears.

How similar studies have performed: Prior observational studies and trials using autologous serum or platelet-derived eye drops and limited reports of cord blood plasma have reported promising epithelial and symptomatic improvements, though randomized evidence remains limited.

Eligibility criteria

Inclusion Criteria

1. Age ≥ 18 years.
2. Male or female.
3. Diagnosis of Dry Eye Disease (DED) with severe keratitis and ocular discomfort related to DED, defined as follows:

   Corneal Fluorescein Staining (CFS) score of 3, 4, or 5 on the modified Oxford scale in at least one eye at the Baseline Visit, combined with at least one of the following criteria:

   i. Schirmer test without anesthesia with a score \<10 mm/5 min in the same eye at the Baseline Visit.

   ii. Ocular Surface Disease Index (OSDI) score of at least 30, or presence of at least two moderate to severe dry eye symptoms with a severity score above 50 (severity assessed on a scale of 0 to 100), including any of the following symptoms: burning/stinging, foreign body sensation, ocular dryness, ocular pain, and blurred/decreased vision at the Baseline Visit.
4. Ability to understand and comply with the protocol requirements (as judged by the investigator).
5. Provision of written informed consent and privacy authorization prior to initiation of any study procedures.
6. At least 3 months of conventional treatment use (cyclosporine 1 mg/ml and/or hyaluronic acid) for DED prior to the Baseline Visit.
7. Willingness and ability to undergo all scheduled examinations and visits during the study.

Exclusion Criteria

1. Active herpetic keratitis or history of ocular herpes.
2. History of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days prior to the Baseline Visit.
3. Any ocular disease other than Dry Eye Disease (DED) requiring topical ocular treatment during the study period.
4. Ocular rosacea and/or severe blepharitis.
5. Progressive pterygium.
6. Concurrent ocular allergy (including seasonal conjunctivitis) or chronic conjunctivitis other than dry eye.
7. Planned insertion of temporary punctal plugs during the study period.
8. Best corrected visual acuity (BCVA) score ≤ 0.1 (decimal notation) in either eye.
9. Unstable systemic disease within 30 days prior to the Baseline Visit (e.g., diabetes with out-of-range blood glucose, thyroid dysfunction, uncontrolled autoimmune disease, ongoing systemic infections) or conditions judged by the investigator as incompatible with study participation.
10. Presence or history of severe systemic allergy.
11. Known hypersensitivity to any of the products used in the study (cyclosporine, fluorescein, lissamine green, hyaluronic acid) or their components.
12. History of ocular malignancy.
13. History of malignancy (other than ocular) within the last 5 years.
14. Any changes within 30 days prior to the Baseline Visit, or anticipated changes during the study, in the dosage of systemic medications that may affect dry eye condition \[e.g., estrogen-progesterone or other estrogen derivatives, pilocarpine, isotretinoin, tetracycline, antihistamines, tricyclic antidepressants, anxiolytics, antimuscarinics, beta-blockers, phenothiazines, omega-3 fatty acids, systemic corticosteroids\]. These treatments are permitted during the study provided their dosage remains stable throughout.
15. Any changes in systemic immunosuppressive therapy within 30 days prior to the Baseline Visit or anticipated changes during the study.
16. History of substance abuse or alcohol dependence.
17. Presence or history of any systemic or ocular disorder, condition, or disease that could interfere with the conduct of study procedures or interpretation of study results.
18. Pregnancy or breastfeeding at the time of the Baseline Visit.
19. Women of childbearing potential unwilling to use a highly effective method of contraception (see section 5.2.2) from the Baseline Visit throughout the treatment period and up to 2 weeks after study completion. Postmenopausal women (defined as ≥ 2 years without menstruation) are exempt from contraception requirements.
20. Participation in a clinical trial involving an investigational product within 30 days prior to the Baseline Visit.
21. Concurrent participation in another clinical trial during the present study.

Where this trial is running

Milan

• Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico — Milan, Italy (Recruiting)

Study contacts

• Principal investigator: Francesco Viola, MD — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Study coordinator: Francesco Viola

Conditions Dry Eye; Cord Blood Platelet Poor Plasma; dry eye disease